Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/007—Methods or devices for eye surgery
  • A61F9/008—Methods or devices for eye surgery using laser
  • A61F9/00821—Methods or devices for eye surgery using laser for coagulation
  • A61F9/00823—Laser features or special beam parameters therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/007—Methods or devices for eye surgery
  • A61F9/008—Methods or devices for eye surgery using laser
  • A61F9/00821—Methods or devices for eye surgery using laser for coagulation
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
  • A61F9/007—Methods or devices for eye surgery
  • A61F9/008—Methods or devices for eye surgery using laser
  • A61F2009/00861—Methods or devices for eye surgery using laser adapted for treatment at a particular location
  • A61F2009/00863—Retina

Definitions

• the invention relates to means for controlling a laser treatment device and a laser treatment device with controlling means.
• Laser photocoagulation is done to reduce the risk of vision loss caused by diabetic retinopathy.
• Diabetic retinopathy is a disease of the retina, the thin tissue that lines the back of the eye. The condition is a complication of diabetes and both eyes are usually affected by the disease.
• nonproliferative diabetic retinopathy develops when diabetes weakens the tiny blood vessels that supply the retina, causing swelling or bleeding in the retina. Changes caused by nonproliferative retinopathy may not affect vision unless fluid and protein from the damaged blood vessels cause swelling in the center of the retina (macula). This condition, called macular edema, can cause severely blurred or distorted central vision.
• Proliferative diabetic retinopathy is the advanced form of diabetic retinopathy.
• the main feature of proliferative retinopathy is the growth of fragile new blood vessels on the surface of the retina. These blood vessels may break easily, bleeding into the middle of the eye and clouding vision. They also form scar tissue that can pull on the retina, causing the retina to detach from the wall of the eye (retinal detachment).
• Laser photocoagulation uses the heat from a laser beam to seal or destroy abnormal, leaking blood vessels in the retina.
• One of two approaches may be used when treating diabetic retinopathy.
• Focal photocoagulation treatment is used to seal specific leaking blood vessels in a small area of the retina, usually near the macula.
• the ophthalmologist identifies individual blood vessels for treatment and makes a limited number of laser burns to seal them off.
• Scatter (pan-retinal) photocoagulation treatment is used to slow the growth of new abnormal blood vessels that have developed over a wide area of the retina.
• the ophthalmologist may make hundreds of laser burns on the retina to stop the blood vessels from growing. The person may need two or more treatment sessions.
• a typical laser treatment device the light from a slit lamp and a laser source are combined and reflected on the eye through some optic elements and other components.
• Retinal photocoagulation is typically performed point-by-point, where each individual dose of laser energy is positioned and delivered by a physician.
• the object of the invention is a solution with which hazardous consequences of adjustments done during a surgical eye operation can be avoided.
• the laser treatment device adapted to treat an eye comprises a laser source producing a laser treatment beam of an adjustable power, means for delivering the beam on a target area of the eye to be treated, a fiber for transporting the laser beam to said delivery means, and means for adjusting parameters for the treatment.
• the device is characterized by control means with the functionality of automatically adjusting the power of the laser treatment beam in accordance with an adjusted parameter.
• the means for controlling the laser treatment device comprise a software implementation for controlling the functionality of the laser treatment device implemented by hardware components, and an interface between the software implementation and the hardware components through which the parameters of the treatment can be adjusted.
• the interface is a graphical user interface seen on a screen of a computer connected to the laser treatment device.
• the system of the invention for controlling laser treatment of an eye comprises said laser treatment device adapted to treat an eye and a computer connected to a monitor with a touch screen that runs suitable software for the laser treatment and connected to the laser treatment device through a graphical user interface by means of which parameters of the treatment can be adjusted.
• the invention is concerned with a software program product run on a computer readable media controlling said laser treatment device.
• the eye treatment, or photocoagulation is performed by delivering a treatment laser beam to the fundus of the eye.
• a certified physician places several hundred laser burns ("spots") in selected areas of the patients' fundus. The burns are used to destroy abnormal blood vessels that are formed in the retina of a diabetic patient. This treatment reduces the risk of severe vision loss for eyes.
• the laser light produced with the laser treatment device is used as an aiming beam
• a single laser source can be used for both the aiming beam and the treatment beam in case the laser beam is used as an aiming beam when it is adjusted to a first power and as a treatment beam when it is adjusted to a second power.
• the aiming beam is produced in the form of a visible alignment pattern of one or several spots showing the target locations for the real treatment beam is projected onto the eye. Doses of laser energy are provided to the treatment locations coincident with the alignment spots.
• a scanner can be used to move the alignment beam from spot to spot on the retina and to move a treatment laser beam from location to location on the retina of the eye.
• the computer connected to a monitor with a touch screen runs suitable software for the laser treatment and is used through a graphical user interface enabling the person that performs the treatment (such as a physician, ophthalmologist or doctor) to adjust suitable settings for the treatment. All the means for adjusting parameters can be separate adjusting means for each variable or parameter or one or more of said adjusting means can be integrated.
• the most common variables or parameters for the treatment available for setting and adjusting are e.g. the beam size, power, shape/geometry and size of the pattern or figure formed on the retina of the eye by single spots of laser light, the duration and intensity of the laser treatment pulse, the mutual distance of the spots and the intensity of the aiming beam.
• further adjustable parameters are the macula grid geometry, the fixation light geometry, and the number and location of spots.
• the laser treatment device of the invention thus include one or two laser sources, a delivery device, such as a slit lamp, an optical fiber to deliver the laser beam from the laser source, scanners to deflect the laser beam onto the retina of the eye, means for adjusting and selecting said parameters, and means for automatically adjusting the power of the treatment beam in accordance with the duration of the laser treatment pulse (beam) selected and/or in accordance with the spot size selected by the adjusting means.
• a delivery device such as a slit lamp
• an optical fiber to deliver the laser beam from the laser source
• scanners to deflect the laser beam onto the retina of the eye
• means for adjusting and selecting said parameters means for automatically adjusting the power of the treatment beam in accordance with the duration of the laser treatment pulse (beam) selected and/or in accordance with the spot size selected by the adjusting means.
• the control means consist of software and an interface, whereas the other components constitute hardware component parts of the device.
• the software controls at least one functionality of the hardware components, such as the laser pulse power and accordingly the hardware components implement the functionality of the laser treatment device under control of the software.
• the control means automatically adjusts the power of the laser treatment beam as a function of the selected spot size of the pattern and/or the duration of the treatment pulse.
• the control means comprise software performing the adjustment needed.
• the implementation of the software can be performed by a calculation algorithm.
• the device's internal system automatically reduces the power level with the power level control means, so that the fluence level is kept on the similar level as before the spot size change.
• the adjusting means can be separate means or integrated with other adjusting means.
• a software/ hardware interface is used for the control.
• the minimum power lever is settled by the system (60mW), by settling means, which can be separate means or integrated other means.
• Fluence 12.7 J/cm2 In order to keep the fluence at its original level in the beginning of the treatment, there has to be a decrease in power.
• the device of the invention automatically reduces the power to a value of 360 mW, thereby maintaining the original fluence value.
• the doctor hims elf does not need to take care of the adjusting of the power to the desired fluence level since the device of the invention adjusts the power automatically. There is thereby no risk that the power adjustment would be forgotten or be wrongly adjusted with catastrophic consequences.
• Figure 1 is a schematic view of a laser treatment system, wherein the invention is implemented
• Figure 2 presents an example of a graphical user interface for the control of the laser treatment device of the invention
• FIG. 3 is a flow scheme describing the role of the software implementation of the invention DETAILED DESCRIPTION
• Figure 1 is a schematic view of a laser treatment system, wherein the invention is implemented.
• the complete laser treatment system can consist of a trolley with a computer 8, a laser module 9 (with a laser source, a possible beam attenuator and a fiber coupling module), and a fiber 4, a slit lamp source 9c, a slit lamp mirror 9b, a slit lamp adapter 5, optics 9a to transport the laser beam and slit lamp light, and electronics of the device (not shown).
• the trolley can of practical reasons be on wheels and be easily movable.
• Reference number 10 represents the eye of a patient to be treated.
• the light from the slit lamp 9c and the laser beam from the laser source (which is inside the module 9) are combined and reflected on the eye 10 through the slit lamp adapter 5 and the optics 9a and further via the mirror 9b that turns the combined beam 90 degrees against the eye 10.
• the computer 8 is preferably a Personal Computer (PC) connected to a monitor 7 with a touch screen 1 1 as a graphical user interface and is fixed to the trolley or to a slit lamp table.
• the computer 8 runs suitable software for the laser treatment and is used through the graphical user interface enabling the person that performs the treatment (such as a physician, ophthalmologist or doctor) to adjust suitable settings for the treatment.
• An example of a possible graphical user interface is described in more detail in figure 2.
• the photocoagulation (or treatment) to be performed by delivering a treatment laser beam to the fundus of the eye takes place with the assistance of the slit lamp 9c or microscope and a contact lens.
• the slit lamp adapter 5 can be integrated with compatible microscopes. Foreseen with computer controllable scanners it produces a variety of different predefined spot patterns to suit several treatment applications. The scanners deflect the laser beam delivered from the laser module by the optical fiber.
• the foot switch connected to the laser module with which the turning on and off of the laser source can be controlled.
• the foot switch or some other switch used by the doctor starts the treatment process.
• the laser emission can be interrupted by releasing the foot.
• the laser wavelengths used can e.g. be green, yellow, red or infrared but the invention is especially signed for green laser light of e.g. 532 nm, which is successfully used for treating retinal diseases.
• Another is a laser light of yellow wavelengths in the range of 560-590 nm.
• a traditional red wavelength can be used as well.
• the wavelength chosen partly depends on the area of the eye to be treated and on which wavelength a given available laser source is able to produce.
• the laser technology that can be used involves e.g. Diode-Pumped Solid-State (DPSS) lasers, which are solid-state lasers made by pumping a solid gain medium, for example, a ruby, a neodymium-doped YAG (Neodymium-Doped Yttrium Aluminum Garnet; Nd:Y 3 AI 5 0i 2 ) crystal with a laser diode or a neodymium-doped YVO (Neodymium- Doped Yttrium Orthovanadate; Nd:YV0 4 ) crystal with a laser diode.
• DPSS Diode-Pumped Solid-State
• An example of another laser technology that can be used are the Optically Pumped Semiconductor Lasers (OPSL), which use a lll-V semiconductor chip as the gain media, and another laser (often another diode laser) as the pump source.
• OPSL Optically Pumped Semiconductor Lasers
• VCSEL Vertical-Cavity Surface-Emitting- Laser
• VECSEL Vertical-External- Cavity Surface-Emitting-Laser
• VECSEL is a small semiconductor laser similar to a vertical-cavity surface-emitting laser (VCSEL) to be used within the green, yellow, red or short Infra Red (IR) range.
• Figure 2 presents an example of a graphical user interface for the control of the laser treatment device of the invention seen on a touch screen 1 1.
• the computer connected to a monitor with the touch screen runs suitable software for the laser treatment and is used through a graphical user interface on the touch screen 1 1 enabling the person that performs the treatment (such as a physician, ophthalmologist or doctor) to adjust suitable settings for the treatment.
• the laser device is operated via the touch screen 1 1 and a smart wheel, which gives the physician the freedom to choose a pattern and select other parameters without removing their eyes from the oculars.
• the smart wheel is a manual control button that allows the user to change parameters during the treatment without having to use the touch screen.
• the smart wheel is connected to the Universal Serial Bus (USB) port of the computer.
• USB Universal Serial Bus
• control means or control buttons suitable for three dimensional (3D) design can be used in the invention such as different kinds of space navigators or a 3D mouse. They can be used to rotate and move objects in three dimensions.
• a type of SpaceNavigator is used in cooperation with a traditional mouse. One hand engages the SpaceNavigator to position the model or navigate the environment while the other hand simultaneously uses the traditional mouse to select, create or edit. All the means for adjusting parameters can be separate adjusting means for each variable or parameter or one or more of said adjusting means can be integrated.
• buttons to click are in figure 2, shape/geometry 13a - 13f and size 14 of the pattern or figure formed on the retina of the eye by single spots of laser light, the duration 15 and power 12 of the laser treatment pulse, the mutual distance 16 of the spots and the intensity of the aiming beam 17 and the interval 18 between the laser pulses.
• Further adjustable settings are the spot size 20 that appears on the screen as selected from the slit lamp adapter.
• Reference numbers 22a shows the spot selection alternative and reference number 22b an outline alternative.
• the presence and geometry of the fixation light can optionally be adjusted with button 23.
• the program with which the settings can be adjusted in the system produces a preview of the spot pattern to visualize the area to be coagulated or treated in the target tissue.
• the selected pattern 19 is a scare of eight spots.
• An aiming beam is produced in the form of a visible alignment pattern of one or several spots showing the target locations for the real treatment beam is projected onto the eye.
• This pattern can be in the form of a square, circle, line, sector, arc, or any other spot formation.
• the spot sizes can e.g. be varied to be 50 ⁇ , 100 ⁇ , 200 ⁇ , 300 ⁇ or 400 ⁇ .
• the pattern is chosen dependency on the form and size of the area to be treated.
• the retinal laser spot sizes range from 100 to 500 ⁇ ,
• the user interface can have a menu for different spot sizes depending on task and/or treatment mode.
• the laser device can also be set to deliver a predetermined pattern of treatment, such as a circle or an arc or other pattern as mentioned above. Also the number of spots to be delivered can be preset or adjusted as well as the radius of the circle.
• further adjustable parameters are the macula grid geometry, the fixation light geometry, and the number and location of spots.
• a slit lamp can be used to deliver the laser light. It is an instrument used in eye care that provides an illuminated and magnified view of a patient's eye.
• the slit lamp typically includes a light projected through a slit to allow for observation of optical cross sections of the eye using an optical portion.
• the light is typically mounted to be adjustable for observation of different portions of the eye.
• the patient is instructed to focus the other eye on a fixation light such that the examined eye is properly oriented.
• the presence and geometry of the fixation light can optionally be adjusted with the adjusting means, which can be separate means or integrated with other adjusting means.
• a macular grid is e.g. an image of horizontal and vertical lines used to monitor a person's central visual field. It is a diagnostic tool that aids in the detection of visual disturbances caused by changes in the retina, particularly the macula.
• the number of spot lights can be limited so that the maximum delivery time does not exceed a set value, e.g. 750 milliseconds.
• the means for adjusting the number of spots can be separate or integrated with other adjusting means.
• the multi-spot pattern can be reduced to a single spot pattern with affecting adjusting means.
• the adjusting means to control single spot pattern, size and/or other aspects of the geometry of the pattern can be implemented by separate adjusting means or be integrated with other controlling means. This feature can be used as a help in titration of an initial power and it allows using fixation light with single spot, e.g. in focal treatment of leaking microaneurysm.
• the size of the pattern can be changed on the screen preferably by using a touch screen and while touching the screen on the place of the pattern and by moving e.g. a finger in a proper direction.
• the adjusting means for the functionality to control the patterns can be separate means or integrated with other adjusting means.
• the location or segment for treatment can be selected either by adjusting means for them or by means of a smart wheel arranged to select the segment.
• the segment geometry can be selected by a finger or some pointing device from the touch screen.
• the adjusting means to interface the touch screen can be separate means or integrated with other adjusting means.
• the software can be used to control the laser beam shape and other parameters by moving a pointing device on the touch screen, a finger or other kind of drawing equipment.
• the power of the treatment beam is mainly determined by the size of the spot(s) in a way that the bigger spot(s) used, the less power is needed since the power per surface area has to be kept within a certain level and is expressed in J/cm 2 .
• the fluence which describes the energy of the laser delivered per unit area, in which case it has the unit of J/cm 2 .
• the area is usually the spot size of the light device.
• the software automatically adjust the power to an appropriate value, which can be seen on the screen at reference number 12 or as a changed fluence at reference number 21 .
• Figure 3 is a flow scheme describing the role of the software implementation of the invention in the laser treatment.
• the inventive idea is to adjust the power of the laser treatment beam automatically when certain conditions and parameters change or are changed.
• the power of the laser treatment beam is mainly determined by the size of the spot(s) and the duration of the laser treatment pulse.
• the laser treatment device of the invention can thus be used in different modes in accordance with these factors and the function of how the power is adjusted by the software depends on the initial power set depending on mode.
• the initial power can either be preprogrammed to a certain treatment or be set in accordance with a so called titration mode, in which the laser power to be used is titrated until an appropriate burn on the eye is achieved on the eye.
• this titration takes place by turning on the computer and laser treatment device in step 1 , where after a variety of parameters as mentioned above are selected as starting parameters in step 2.
• the starting parameters might appear as default values on the user interface to be seen on the screen of the computer each time the computer and laser device are turned on. Different recommendations for some common situations and treatments might be preprogrammed as default values.
• Figure 2 shows how the values of the parameters can be seen on the screen.
• the software can be used to control the laser beam shape and other parameters by moving a pointing device on the touch screen, a finger or other kind of drawing equipment.
• Still one preparing operation is the alignment of the aiming beam in step 3.
• the laser light produced with the laser source is used as an aiming beam, the power of which is allowed to be 390 microwatt, i.e. 0,39 milliwatt at the most, which is a level that is considered safe for the eye. Said level below 390 ⁇ is defined in the laser standards.
• the laser power is titrated (laser pulses of successively higher power are delivered) in step 4 until an appropriate burn is achieved when using the titration mode.
• the power can be adjusted by e.g. using a touch button on the screen as is seen in figure 2 or by means of a smart wheel. Once an appropriate burn has been achieved, the laser treatment device is ready to deliver the selected pattern of treatment.
• the laser treatment is then performed in step 5.
• parameters have to be readjusted during a treatment. There might e.g. be different areas to be treated on the retina of the eye during a single treatment and some areas might requires a different power level. Further adjustments might have to do with the fact that some patterns are better suited for given areas than other ones.
• step 6 the pulse duration and/or the spot size is corrected to a new value.
• the software controls the functionality of the laser treatment device, the laser pulse power is automatically adjusted in step 7 accordance with a preprogrammed function of the adjusted value.
• the control means comprising the software automatically adjusts the power of the laser treatment beam as a function of the selected spot size of the pattern and/or the duration of the treatment pulse.
• the implementation of the software can be performed by e.g. a calculation algorithm.
• the pulse duration is within the range of 10-650 milliseconds, usually 100 - 200 milliseconds10-30 ms in a multisport pattern mode. In a single spot mode, when individual spots are treated one-by-one, the longer pulses of more than 30 ms can be used.
• the device's internal system automatically reduces the power level with the power level control means, so that the fluence level is kept on the similar level as before the spot size change.
• the adjusting means can be separate means or integrated with other adjusting means.
• a software/ hardware interface is used for the control.
• the minimum power lever is settled by the system (60mW), by settling means, which can be separate means or integrated other means.
• the corresponding power beam or fluence automatically set, adjusted and/or hold by the program on a desired level is seen on the screen.
• the power is from 50 - 1500mW, more usually between 100 and 750 mW.
• step 8 the treatment continues with the new values in a safe way the power and fluence being kept on a desired and safe level.

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• Health & Medical Sciences (AREA)
• Ophthalmology & Optometry (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Optics & Photonics (AREA)
• Surgery (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Physics & Mathematics (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Life Sciences & Earth Sciences (AREA)
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• 2013
  • 2013-04-12 FI FI20135360A patent/FI20135360L/fi not_active Application Discontinuation
  • 2013-09-05 EP EP13766581.6A patent/EP2892478A1/de not_active Withdrawn
  • 2013-09-05 WO PCT/FI2013/050859 patent/WO2014037620A1/en active Application Filing

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